Liraglutide

Product NDC
71288-563
11-digit product format
712880563
Labeler code
71288
Product ID
71288-563_c4f6adef-1b2a-4e7c-b7a9-b19d4ed1df36
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
liraglutide
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA218115
Marketing category
ANDA
Marketing start
2025-04-02
Substance
LIRAGLUTIDE
Active strength
6 mg/mL
Pharmacologic classes
GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Liraglutide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIRAGLUTIDE6 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii839I73S42A
Rxcui897122

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d8dac6c8-0045-42cf-b357-c3350b4ada5cProduct name220251021
0dd952e2-ff48-4739-9b8d-72ae0b326834Product name220200323
ce962b7e-f9f8-43e6-8d30-41514e79f3e4Product name120190201
2f360a13-6ea8-4c2b-b2ef-10133c2836d9Product name120150316

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-563-84ML - Milliliter71288-563b8c732b2-a8ab-497d-ba86-2aa769769ee512025-05-14
71288-563-85ML - Milliliter71288-563c7e6e826-1813-48b3-bdd3-80584531a3e412025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-563LIRAGLUTIDE INJECTION [MEITHEAL PHARMACEUTICALS INC.]7Current NDC20250406_0efc3a89-211a-4496-baab-e8265e07de2b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
897122liraglutide 6 MG/ML in 3 ML Pen InjectorPSN0efc3a89-211a-4496-baab-e8265e07de2b8
8971223 ML liraglutide 6 MG/ML Pen InjectorSCD0efc3a89-211a-4496-baab-e8265e07de2b8
897122liraglutide 18 MG per 3 ML Pen InjectorSY0efc3a89-211a-4496-baab-e8265e07de2b8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71288-563-84712880563843 SYRINGE, PLASTIC in 1 CARTON (71288-563-84) / 3 mL in 1 SYRINGE, PLASTIC2025-04-02NoNoHistorical
71288-563-85712880563852 SYRINGE, PLASTIC in 1 CARTON (71288-563-85) / 3 mL in 1 SYRINGE, PLASTIC2025-04-02NoNoHistorical